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The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azzalure/Dysport as single treatment | Experimental | Azzalure/Dysport as single treatment at initial treatment |
|
| Filler as single treatment | Experimental | Filler as single treatment at initial treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azzalure or Dysport | Drug | Glabellar lines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance | Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?". | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance | Subjects showing superior "Global facial aesthetic appearance" at 1, 7 and 13 months. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?". |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Kestemont, MD | Clinique Science et Beauté, Antibes, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brazilian Center for Studies in Dermatology | Porto Alegre | 90570-040 | Brazil | |||
| Mediti Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31334927 | Result | Heden P, Hexsel D, Cartier H, Bergentz P, Delmar H, Camozzato F, Siega C, Skoglund C, Edwartz C, Norberg M, Kestemont P. Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid. J Drugs Dermatol. 2019 Jul 1;18(7):682-689. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azzalure/Dysport as Single Treatment | Azzalure/Dysport as single treatment at initial treatment Azzalure or Dysport: Upper facial lines Restylane or Emervel filler: Facial tissue augmentation Restylane Skinbooster: Facial skin rejuvenation |
| FG001 | Filler as Single Treatment | Filler as single treatment at initial treatment Azzalure or Dysport: Upper facial lines Restylane or Emervel filler: Facial tissue augmentation Restylane Skinbooster: Facial skin rejuvenation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single Treatment Phase (6 Months) |
|
| |||||||||||||||||||||
| Combination Treatment Phase (up to 18 m) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azzalure/Dysport as Single Treatment | Azzalure/Dysport as single treatment at initial treatment Azzalure or Dysport: Upper facial lines Restylane or Emervel filler: Facial tissue augmentation Restylane Skinbooster: Facial skin rejuvenation |
| BG001 | Filler as Single Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance | Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?". | One subject in Group A was excluded from the analysis due to the wrong photographs being used in the evaluation. | Posted | Number | percentage of subjects | 7 months |
|
18 months
The Arms/Groups are combined for the combination treatment phase, since all subjects received the same treatment during that time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | After Single Treatment - Azzalure/Dysport | Subjects receiving Azzalure/Dysport as the initial single treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA version 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
Small number of subjects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Development | Q-Med AB | + 46 (0) 18 474 90 00 | reception.seupp@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2014 | Aug 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Restylane or Emervel filler | Device | Facial tissue augmentation |
|
|
| Restylane Skinbooster | Device | Facial skin rejuvenation |
|
|
| 1, 7 and 13 months |
| Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator | The 5-graded GAIS was used to assess the facial aesthetic improvement from Baseline by responding to the question: "How would you describe the subject's global facial aesthetic appearance compared to the photographs taken before treatment at Baseline?". The following rating was used: Very much improved, Much improved, Somewhat improved, No change, or Worse. Criteria for improvement met for those subjects that were assessed as Very much improved, Much improved, or Somewhat improved. GAIS score was assessed by three blinded evaluators at Months 1, 7, and 13 (1 month after single treatment, 1 month after first combined treatment, and 1 month after second combined treatment). The blinded evaluators performed the evaluations retrospectively using 2D-photographs from each follow-up visit and from Baseline (Visit 1). | 1, 7, and 13 months |
| Number of Participants Satisfied With Facial Appearance | The subjects were asked to answer the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is fulfilled for those subjects that answered ""Very/somewhat satisfied". | 7 and 13 months |
| Number of Participants for Which the Investigator is Satisfied With the Outcome | The Investigators answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria met for those subjects that the Investigator answered "Very/somewhat satisfied". | 7 and 13 months |
| Percentage of Subjects Improved in Wrinkle Severity Score | The wrinkle severity of the Azzalure/Dysport treated glabellar lines at maximum frown was evaluated by the Investigator. A validated 5-graded photonumeric grading scale was used, where each severity grade was illustrated by a set of photographs. 0 = No glabella lines
| 7 and 13 months |
| Injected Volume of Study Products at Initial Single Treatment | Evaluation of Azzalure/Dysport (Group A)/Filler (Group B) volume injected at initial single treatment (baseline). | Baseline |
| Paris |
| Antibes |
| 06160 |
| France |
| Centre Medical Saint-Jean | Arras | 62000 | France |
| Akademikliniken | Stockholm | 115 42 | Sweden |
| NOT COMPLETED |
|
|
Filler as single treatment at initial treatment Azzalure or Dysport: Upper facial lines Restylane or Emervel filler: Facial tissue augmentation Restylane Skinbooster: Facial skin rejuvenation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking | Count of Participants | Participants |
|
Azzalure/Dysport as single treatment at initial treatment
Azzalure or Dysport: Upper facial lines
Restylane or Emervel filler: Facial tissue augmentation
Restylane Skinbooster: Facial skin rejuvenation
| OG001 | Filler as Single Treatment | Filler as single treatment at initial treatment Azzalure or Dysport: Upper facial lines Restylane or Emervel filler: Facial tissue augmentation Restylane Skinbooster: Facial skin rejuvenation |
|
|
| Secondary | Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance | Subjects showing superior "Global facial aesthetic appearance" at 1, 7 and 13 months. Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment). The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: "At which set of photographs does the subject show superior global facial aesthetic appearance?". | Six subjects that were assessed differently by all three evaluators were excluded from the analysis. In addition, one subject was excluded from the analysis due to wrong photographs at Month 1. | Posted | Number | percentage of subjects | 1, 7 and 13 months |
|
|
|
| Secondary | Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator | The 5-graded GAIS was used to assess the facial aesthetic improvement from Baseline by responding to the question: "How would you describe the subject's global facial aesthetic appearance compared to the photographs taken before treatment at Baseline?". The following rating was used: Very much improved, Much improved, Somewhat improved, No change, or Worse. Criteria for improvement met for those subjects that were assessed as Very much improved, Much improved, or Somewhat improved. GAIS score was assessed by three blinded evaluators at Months 1, 7, and 13 (1 month after single treatment, 1 month after first combined treatment, and 1 month after second combined treatment). The blinded evaluators performed the evaluations retrospectively using 2D-photographs from each follow-up visit and from Baseline (Visit 1). | Number of analyzed subjects varied over time due to drop-outs from study. Data not presented "Per Arm", since statistical analysis was only performed on both groups combined after the combination treatments (since the groups receive the exact same treatment during the combination treatment). | Posted | Number | 95% Confidence Interval | % participants | 1, 7, and 13 months |
|
|
|
| Secondary | Number of Participants Satisfied With Facial Appearance | The subjects were asked to answer the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is fulfilled for those subjects that answered ""Very/somewhat satisfied". | Number of analyzed subjects varied over time due to drop-outs from study. | Posted | Count of Participants | Participants | 7 and 13 months |
|
|
|
| Secondary | Number of Participants for Which the Investigator is Satisfied With the Outcome | The Investigators answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria met for those subjects that the Investigator answered "Very/somewhat satisfied". | Number of analyzed subjects varied over time due to drop-out of study subjects. | Posted | Count of Participants | Participants | 7 and 13 months |
|
|
|
| Secondary | Percentage of Subjects Improved in Wrinkle Severity Score | The wrinkle severity of the Azzalure/Dysport treated glabellar lines at maximum frown was evaluated by the Investigator. A validated 5-graded photonumeric grading scale was used, where each severity grade was illustrated by a set of photographs. 0 = No glabella lines
| Number of analyzed subjects was reduced over time due to drop-out of study subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | 7 and 13 months |
|
|
|
| Secondary | Injected Volume of Study Products at Initial Single Treatment | Evaluation of Azzalure/Dysport (Group A)/Filler (Group B) volume injected at initial single treatment (baseline). | Posted | Mean | Standard Deviation | Speywood Units/mL | Baseline |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 3 |
| 32 |
| EG001 | After Single Treatment - Filler | Subjects receiving Filler as the initial single treatment. | 0 | 33 | 1 | 33 | 4 | 33 |
| EG002 | After 1st Combination Treatment - All Subjects | Both treatment groups combined, since they received the same treatment during the combination treatment phase. | 0 | 62 | 0 | 62 | 22 | 62 |
| EG003 | After 2nd Combination Treatment - All Subjects | Both treatment groups combined, since they received the same treatment during the combination treatment phase. | 0 | 61 | 0 | 61 | 15 | 61 |
| Implant site bruising | General disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Implant site swelling | General disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
|
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| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Month 13 |
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| Month 13 |
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| Month 13 |
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| Month 13 |
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| Month 13 |
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